A Multiple Dose Study Of PD-0360324 In Patients With Active Cutaneous Lupus Erythematosus

Cutaneous Lupus Erythematosus Clinical Trial

Official title:

A Randomized, Subject And Investigator-Blinded (Sponsor-Open), Placebo-Controlled Study To Evaluate The Safety, Tolerability, And Preliminary Efficacy Of Multiple Ascending Doses Of PD- 0360324 In Subjects With Active Cutaneous Lupus Erythematosus (CLE)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01470313
• Other study ID #: A6261008
• Status: Terminated
• Phase: Phase 1
• First received: November 9, 2011
• Last updated: January 27, 2014
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the safety and tolerability of multiple intravenously administered doses of PD-0360324 in patients with cutaneous lupus erythematosus. Changes in disease activity will also be evaluated.

Description:

The trial was terminated prematurely on Oct 15, 2013 due to a business decision. The decision to terminate the trial was not based on any clinical safety or efficacy concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and/or female subjects between the ages of 21 to 70 who have a clinical diagnosis of either discoid cutaneous lupus erythematosus or subacute cutaneous lupus erythematosus with or without systemic lupus erythematosus prior to screening that has been confirmed by evaluation of skin biopsy sample.

• Active disease at both screening and baseline (Day 1) defined by a CLASI score of greater than or equal to 10.

• Intolerance to antimalarial therapy or more than 3 months of antimalarial therapy with disease activity.

Exclusion Criteria:

• Use of greater than or equal to 20 mg or prednisone (or equivalent) within 3 months of Day 1.

• Signs or symptoms or relevant history of a viral, bacterial, fungal, and parasitic infection, or recent history of repeated infections

• Subjects with evidence of past or active tuberculosis

• Pregnant, planning to get pregnant, and/or lactating females or males planning to father a child within time period of the study or subsequent exclusionary period.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Lupus Erythematosus
• Lupus Erythematosus, Cutaneous
• Lupus Erythematosus, Systemic

Intervention

Drug:
• PD-0360324
Subjects will receive PD-0360324 intravenously in 3 different cohorts. The cohorts will be evaluated in ascending fashion. The doses planned are 100 mg every other week for 3 months, 150 mg every other week for 3 months, and 200 mg every 4 weeks for 3 months.
• Placebo
Placebo is normal saline. The timing of placebo administration will depend of the dosing frequency of the cohort (either every other week for 3 months or every 4 weeks for 3 months).

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Markham	Ontario
Moldova, Republic of	Pfizer Investigational Site	Chisinau
United States	Pfizer Investigational Site	Anniston	Alabama
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Clarksburg	West Virginia
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Ducansville	Pennsylvania
United States	Pfizer Investigational Site	Fort Gratiot	Michigan
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	Jackson	Tennessee
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Norfolk	Virginia
United States	Pfizer Investigational Site	Orange Park	Florida
United States	Pfizer Investigational Site	Oxford	Alabama
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Rapid City	South Dakota
United States	Pfizer Investigational Site	Rapid City	South Dakota
United States	Pfizer Investigational Site	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of PD- 0360324 will be assessed by physical examinations, adverse event and infection monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.		16 Weeks	Yes
Secondary	Efficacy of PD-0360324 based upon reduction of severity of symptoms as measured using the activity score of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)		12 Weeks	No
Secondary	Measure changes in systemic features using the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)		12 Weeks	No
Secondary	Measure changes in biomarkers		12 weeks	No
Secondary	Assess health outcomes measures		12 Weeks	No
Secondary	Evaluate the Pharmacokinetics of PD-0360324		16 Weeks	No

External Links

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